At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 227 enrolled
Drug / intervention
Enzalutamide +1 moredrug
Likely dose
Enzalutamide oral dose not specified in provided textAI-extracted
Key inclusion· 3
- ✓Histologically proven prostate adenocarcinoma diagnosed within 6 months with ≥10 core biopsy submitted for central review
- ✓Low-risk disease (T1c-T2a, PSA <10, GS ≤6) OR intermediate-risk (T2b-T2c, PSA <20, GS ≤7 with 3+4 pattern only), both with ECOG ≤2 and life expectancy >5 years
- ✓Ability to swallow study drugs and comply with study requirements
Key exclusion· 9
- ✕Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
- ✕Very low risk category (T1c, GS ≤6, PSA <10 ng/mL, <3 positive biopsy cores, ≤50% cancer per core, PSA density <0.15 ng/mL/g)
- ✕Prior TURP or transurethral microwave thermotherapy of prostate
- ✕Presence of metastatic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT)
In Brief
A Phase 2 clinical trial evaluating Enzalutamide and Active Surveillance for Prostate Cancer. Completed, enrolled 227 participants across 54 sites in 2 countries.
Detailed Summary
The primary purpose of this study was to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCanada, United States
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJun 2016
First PostedJun 2016
Primary CompletionAug 2020
TodayJul 2026
First PostedJun 15, 2016
Enrollment StartJun 9, 2016
Primary CompletionAug 28, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 10.0 years ago
Interventions
Enzalutamidedrug
Oral
Active Surveillanceother